Thursday, 30 April 2020

The
European Union Medical Device Directives (MDD) 93/42/EEC will transition to the
Medical Device Regulation (MDR) 2017/745 on 26 May 2020. New changes stemming from the transition
establishes “economic operator” (e.g. distributor, importer) and states that
each economic operator and previous operators in the distribution chain must
adhere to regulations.

Medical
Devices Regulation (EU) 2017/745 will replace the current Medical Device
Directive (MDD) and the Active Implantable Medical Device Directive (AIMD),
whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both
regulations bring a series of important improvements to conformity assessment
for medical devices with the intention to:

Improve
the quality, safety and reliability of medical devices placed on the European
market.

Strengthen
transparency of information related to medical devices for consumers and practitioners.

Wednesday, 29 April 2020

New
FDA guidance provides recommendations to applicants seeking licensure under
section 351(k) of the Public Health Service (PHS) Act of a proposed biosimilar
or proposed interchangeable biosimilar for fewer than all of the reference
product’s licensed conditions of use.

This
guidance also provides recommendations on the submission of a supplement to a
licensed 351(k) biologics license application (BLA) seeking to add a condition
of use that previously has been licensed for the reference product to the
labeling of a licensed biosimilar or interchangeable product, including
considerations related to the timing of such submissions.

Tuesday, 28 April 2020

Shortly
after the National Aeronautics and Space Administration (NASA) installed the
water dispenser aboard the ISS in 2009, periodic sampling showed that two
bacteria, Burkholderia cepacia and later on, Burkholderia contaminans
were contaminating the drinking water. These microbes belong to a group of
related Burkholderia species that cause opportunistic lung infections in
people with underlying health conditions and are very difficult to kill using
common sterilization techniques. The bacteria have persisted in the water
dispenser despite periodic flushing with an extra-strength iodine cleaning
solution.

To
learn more about these bacteria, researchers sequenced the genomes of 24
strains collected from 2010 to 2014. All of the B. cepacia and B.
contaminans strains were highly similar, and likely descended from original
populations of these two bacteria that were present in the water dispenser when
it left Earth.

The
researchers conclude that the two bacterial species living within the dispenser
are no more dangerous than similar strains that might be encountered on Earth.
In the event of an infection, the bacteria can still be treated with common
antibiotics.

The
authors add: "Within each species, the 19 B. cepacia and 5 B.
contaminans recovered from the ISS were highly similar on a whole genome
scale, suggesting each population may have stemmed from two distinct founding
strains. The differences that can be observed among the isolates of the same
species are primarily located within putative plasmids. We find that the
populations of Burkholderia present in the ISS PWS are likely are not
more virulent than those that might be encountered on planet, as they maintain
a baseline ability to lyse macrophage, but remain susceptible to clinically
used antibiotics."

Monday, 27 April 2020

Contaminated flexible endoscopes are the medical devices occasionally associated with outbreaks of health care-associated infection. To minimise the risk, effective cleaning and disinfection of flexible endoscopes must be undertaken. For this process to be effective, several steps need to be followed in a controlled manner. The first step, where a detergent is used at the pre-washer / disinfectant stage, is critical for the removal of soil and in preventing a biofilm community from developing. This step requires the use of a suitable detergent by following a detailed protocol.

Enzymatic detergents are considered to be more effective due to their ability to digest different types of soils and hence facilitate the cleaning process. However, there are additional factors that need to be controlled when using these types of detergent, not least healthcare worker safety. This article examines the differences between these detergents, specifically for the manual cleaning of flexible endoscopes, and considers the factors that need to be practiced for the safe and effective application of enzymatic detergents.

Sunday, 26 April 2020

Scientists
generate dark-field images by fitting standard microscopes with often costly
components to illumine the sample stage with a hollow, highly angled cone of
light. When a translucent sample is placed under a dark-field microscope, the
cone of light scatters off the sample's features to create an image of the
sample on the microscope's camera, in bright contrast to the dark background.

Now,
engineers at MIT
have developed
a small, mirrored chip that helps to produce dark-field images, without
dedicated expensive components. The chip is slightly larger than a postage
stamp and as thin as a credit card. When placed on a microscope's stage, the
chip emits a hollow cone of light that can be used to generate detailed
dark-field images of algae, bacteria, and similarly translucent tiny objects.

The
new optical chip can be added to standard microscopes as an affordable,
downsized alternative to conventional dark-field components. The chip may also be
fitted into hand-held microscopes to produce images of microorganisms in the
field.

Saturday, 25 April 2020

Eating
a Mediterranean diet for a year boosts the types of gut bacteria linked to
'healthy' ageing, while reducing those associated with harmful inflammation in
older people, indicates a five-country study.

As
ageing is associated with deteriorating bodily functions and increasing
inflammation, both of which herald the onset of frailty, this diet might act on
gut bacteria in such a way as to help curb the advance of physical frailty and
cognitive decline in older age, suggest the researchers.

Previous
research suggests that a poor/restrictive diet, which is common among older people,
particularly those in long term residential care, reduces the range and types
of bacteria (microbiome) found in the gut and helps to speed up the onset of
frailty.

The
researchers therefore wanted to see if a Mediterranean diet might maintain the microbiome
in older people's guts, and promote the retention or even proliferation of
bacteria associated with 'healthy' ageing.

They analysed the
gut microbiome
of 612 people aged 65 to 79, before and after 12 months of either eating their
usual diet (n = 289) or a Mediterranean diet (n = 323), rich in fruits,
vegetables, nuts, legumes, olive oil and fish and low in red meat and saturated
fats, and specially tailored to older people (NU-AGE diet).

The
participants, who were either frail (n=28), on the verge of frailty (n=151), or
not frail (n=433) at the beginning of the study, lived in five different
countries: France, Italy, Netherlands, Poland, and the UK.

Sticking
to the Mediterranean diet for 12 months was associated with beneficial changes
to the gut microbiome. It was associated with stemming the loss of bacterial
diversity; an increase in the types of bacteria previously associated with
several indicators of reduced frailty, such as walking speed and hand grip
strength, and improved brain function, such as memory; and with reduced
production of potentially harmful inflammatory chemicals.

More
detailed analysis revealed that the microbiome changes were associated with an
increase in bacteria known to produce beneficial short chain fatty acids and a
decrease in bacteria involved in producing particular bile acids,
overproduction of which are linked to a heightened risk of bowel cancer,
insulin resistance, fatty liver and cell damage.

Friday, 24 April 2020

A
team of Cambridge scientists working on the intersection between biology and
computation has found that random gene activity helps patterns form during
development of a model multicellular system.

We
all start life as a single cell, which multiplies and develops into specialised
cells that carry out different functions. This complex process relies on
precise controls along the way, but these new findings suggest random processes
also contribute to patterning.

A
biofilm develops when free-living single-celled bacteria attach to a surface
and aggregate together to start multiplying and spreading across the surface.
These multiplying individual cells mature to form a three-dimensional structure
that acts like a multicellular organism.

And
while individual cells can survive on their own, these bacteria prefer to work
together with biofilms being the dominant form found in nature.

The
biofilm consortium provides bacteria with various survival advantages like
increased resistance to environmental stresses.

The
researchers developed a new time-lapse microscopy technique to track how
genetically identical single cells behave as the living biofilm developed.

Thursday, 23 April 2020

ICH
has published a new document: “Guideline on reproductive toxicology: Detection
of Toxicity to Reproduction for Human Pharmaceuticals” [ICH S5 (R3)]

The
purpose of this document is to recommend international standards for, and
promote harmonization of, the assessment of nonclinical developmental and
reproductive toxicity (DART) testing required to support human clinical trials
and marketing authorization for pharmaceuticals. The guideline describes
potential strategies and study designs to supplement available data to
identify, assess, and convey risk.

General
concepts and recommendations are also provided that should be considered when
interpreting study data. This is a revision of the ICH guideline “S5 Detection
of Toxicity to Reproduction for Medicinal Products” that was originally
published in 1993. This revision brings the guideline into alignment with other
ICH guidelines, elaborates on the use of exposure margins in dose level
selection, incorporates a section on risk assessment, and expands the scope to
include vaccines and biopharmaceuticals. It also describes qualification of
alternative assays, potential scenarios of use, and provides options for
deferral of developmental toxicity studies. To assess a human pharmaceutical’s
effect on reproduction and development, there should generally be information
available that addresses the potential impact of exposure to a pharmaceutical
and, when appropriate, its metabolites (ICH M3, ICH S6) on all stages of
reproduction and development.

Wednesday, 22 April 2020

The
section on International collaboration on GMP inspections has been updated in
regard to manufacturers of sterile medicines. EMA and its
European and international partners have launched a pilot programme to share
information on GMP inspections of manufacturers of sterile medicines located
outside the participating countries and to organise joint inspections of
manufacturing sites of common interest.

The
prerequisites for sterile products are:

They
are sterile (in all probability, based on the control of sterility

assurance).

Pyrogen
free (apyrogenic).

Free
of visible particles

Other
key quality attributes for sterile products are:

Chemical/biological
purity.

Correct
dose/strength – correctly labelled .

Correct
physical form e.g. colour, particle size, viscosity.

No
physical contaminants.

Batch release is
the process of reviewing and approving all pharmaceutical product manufacturing
and control records and it performed by the Quality Unit to determine
compliance with all established approved written procedures before a batch is
released. The process of batch release, and the authority and training of the
persons eligible to do so, varies according to different GMP systems.

The
products in scope include sterile medicines for human use of chemical origin
and certain therapeutic biotechnology - derived products, such as monoclonal
antibodies and recombinant proteins. Vaccines, cell and gene therapies and
plasma derived pharmaceuticals are currently out of the scope of this pilot.

Tuesday, 21 April 2020

EDQM has published a guidance for the qualification of Atomic Absorption / Atomic Emission
Spectrometers.

The document is the tenth Annex of the core document “Qualification of Equipment”, and
it should be used in combination with it when planning, performing and documenting the Atomic
absorption (AA) spectrometer/ Atomic emission (AE) spectrometer qualification process. For AE
spectrometer only atomization in flame is considered (Inductively coupled plasma-atomic emission
spectrometry is not covered by this guideline).

The core document contains the Introduction and general forms for Level I and II of qualification,
which are common to all type of instruments and the present annex contains instrument-related
recommendations on parameters to be checked at Level III and IV of qualification and the
corresponding typical acceptance limits, as well as practical examples on the methodology that can
be used to carry out these checks.

The frequency of performing the checks should be defined by
each OMCL.
Level III (Periodic and motivated instrument calibration/checks) and IV (In-use instrument checks)
qualifications must be carried out as an ISO 17025 requirement. Requirements and (if applicable)
corresponding typical acceptance limits (given in bold) should be applied; however other
appropriately justified approaches are acceptable. Exemplary procedures provided in this
document have non-binding character. They can be helpful when carrying out the required
qualification.

Nevertheless, it is left to the professional judgement and background experience of
each OMCL to decide on the most relevant procedures to be undertaken in order to provide
evidence that their AA/ AE spectrometers are working properly and are suitable for their intended
use. If the qualification of equipment is done by the manufacturer or an external service provider,
it is the responsibility of the OMCL to make sure that this is in line with the requirements set out in
this guideline.

Monday, 20 April 2020

A new text has been issued, designed to help identify and ameliorate fungal and mold problems and contains a wealth of information as a guide and reference. Many topics are discussed relevant to the food and agriculture industries, including the biology of fungi, outbreaks associated with pharmaceutical drug products and medical devices, mycotoxins, fungal biodegradation and remediation, and strategies for a rapid and accurate fungal identification. The text also contains a lengthy fungal glossary.

The book is Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.

I'm pleased to have contributed two chapters:Sandle, T.
(2020) An anatomy of fungal spores: Formation, dispersal and transfer
risk. In Moldenhauer, J. (Ed.) Fungi: A handbook for Life Science
Manufacturers and Researchers, DHI Publishing, River Grove, IL, USA, pp101-148Sandle, T.
(2020) Investigating sources of fungi in pharmaceutical and healthcare
facilities and taking appropriate action. In Moldenhauer, J. (Ed.) Fungi:
A handbook for Life Science Manufacturers and Researchers, DHI Publishing,
River Grove, IL, USA, pp247-286The book is available via the PDA Bookstore.

Saturday, 18 April 2020

The
Aurum Institute and its partners, as part of the IMPAACT4TB project, have announced
that five high-burden TB countries will roll out a new, shorter drug regimen
(known as 3HP) to prevent TB.

Countries
that will initially provide the new regimen with funding from Unitaid, U.S.
PEPFAR and the Global Fund include Cambodia, Ethiopia, Kenya, Malawi, South
Africa and Zimbabwe. More than 120,000 patient courses of 3HP will be delivered
by the project to 12 countries in 2020. An additional 1 million patient courses
are expected to reach low- and middle-income countries by the end of the year,
through the combined support of Unitaid, Global Fund, the Stop TB Partnership’s
Global Drug Facility (GDF) and PEPFAR.

The
new regimen consists of three months of rifapentine and isoniazid treatment.
The previous standard of care—isoniazid preventive therapy (IPT)—was long and
complex, with people required to take a pill daily for six to 36 months. The
3HP regimen, taken only once a week for 12 weeks, offers numerous benefits for
infected individuals, clinicians and programs. Evidence shows that it’s as
effective as IPT in preventing progression to active TB disease, has fewer side
effects, more patients complete the regimen and is easier for patients to take.

“Effective
TB prevention will be a game-changer in the global fight to eliminate tuberculosis,”
said Robert Matiru, director of programmes at Unitaid. “This new, shorter
regimen, which has until now been unaffordable, offers a great opportunity to
turn the tide against TB and protect those who are at highest risk. Preventing
this deadly, airborne disease is even more important at a time when the entire
world fights to control the threat of COVID-19 and where health systems are
being stretched beyond their limits.”

TB
remains the world’s deadliest infectious disease. In 2018 alone, 10 million
people fell ill from the disease which killed around 1.5 million people, over
95% of whom were living in low- and middle-income countries. TB can lie dormant
for decades before it strikes; this is called “latent TB.” People with latent
infection—almost a quarter of the globe—have no symptoms, are not contagious
and most of them don’t know they are infected. If left untreated, latent
infection can develop into active TB, the form of TB that makes people sick and
is capable of being transmitted from one person to another.

“This
is an exciting new step in the fight to end TB, as it is safer, shortens the
duration of preventive therapy and provides more options for those at highest
risk of developing active TB,” said Dr Tereza Kasaeva, Director of the Global
TB programme at WHO. “WHO, through its regional and country offices, is
committed to support scale-up of TB preventive treatment in countries to
achieve the UN HLM targets. These countries will pave the way for 3HP rollout
in other TB high burden countries.”

During
this first phase, 3HP will first be given to those at highest risk of
progressing from TB infection to TB disease, notably people living with HIV
(PLHIV) and children under the age of five. People living with HIV are 20 to 37
times more likely to move from latent to active TB than those without HIV
infection. Often, their infection goes unnoticed until it’s too late, and as a
result people being successfully treated for HIV are now dying from TB.

At
the UN High-Level Meeting on TB in 2018, world leaders committed to providing
TB preventive therapy to at least 30 million people, including 6 million people
living with HIV, by 2022, 4 million children under 5 years and 20 million
household contacts.

“Children
up to five years of age are at highest risk of progressing from TB infection to
disease, yet only about 25% of those who are eligible for it start TB
preventive therapy,” said Dr Matteo Zignol, Unit Head a.i., TB prevention,
diagnosis, treatment, care and innovation, WHO Global TB Programme. “The
scale-up of 3HP among these vulnerable populations will go a long way towards
not only saving lives, but also reducing the overall burden of TB disease.”

In
October 2019, Unitaid, the Global Fund and Sanofi announced a new price
agreement for rifapentine (Priftin®), which drastically discounted the price of
3HP. The agreement with Sanofi lowered a patient treatment course of Priftin®
from $45 to $15 (a 66% discount). The discounted price was made available to
the public sectors of low-income countries, lower-middle income countries and
upper-middle income countries with a high burden of TB and TB/HIV.

“As
of 2018, only 65 countries reported initiating 1.8 million people living with
HIV and around 350,000 children under the age on TB preventive therapy—well
below the targets set at the UN High-Level Meeting on TB which took place in
September 2018,” said Gavin Churchyard, founder and CEO of the Aurum Institute.
“Until recently, price remained a key barrier to scale-up of short course
regimens such as 3HP. Now that this barrier has been removed, it’s time to get
serious about preventing TB, particularly during the SARS-CoV2 pandemic, as
there is some evidence to suggest that active TB may worsen the clinical
outcome of Covid19 disease.”

“Unitaid
is committed to establishing a healthy market for TB preventive therapy, in
line with the political commitments made at the UN high-level meeting on TB,”
said Philippe Duneton, Unitaid Executive Director a.i. “Moving forward, we
intend to support the entry of at least one more generic supplier of the FDC,
as well as other rifapentine-based formulations, including for children.”

“This
is only the first step, and in the coming months the Aurum Institute and its
IMPAACT4TB partners will be working to roll out 3HP to all 12 of its project
countries, which represent almost 50% of the global TB burden,” said Karin
Kanewske Turner, Director of the IMPAACT4TB Project, from the Aurum
Institute.

Friday, 17 April 2020

Graphite nanoplatelets integrated into plastic medical surfaces can prevent infections, killing 99.99 per cent of bacteria which try to attach – a cheap and viable potential solution to a problem which affects millions, costs huge amounts of time and money, and accelerates antibiotic resistance. This is according to research from Chalmers University of Technology, Sweden, in the journal Small.

Every year, over four million people in Europe are affected by infections contracted during health-care procedures, according to the European Centre for Disease Prevention and Control (ECDC). Many of these are bacterial infections which develop around medical devices and implants within the body, such as catheters, hip and knee prostheses or dental implants. In worst cases implants need to be removed.

Bacterial infections like this can cause great suffering for patients, and cost healthcare services huge amounts of time and money. Additionally, large amounts of antibiotics are currently used to treat and prevent such infections, costing more money, and accelerating the development of antibiotic resistance.

“The purpose of our research is to develop antibacterial surfaces which can reduce the number of infections and subsequent need for antibiotics, and to which bacteria cannot develop resistance. We have now shown that tailored surfaces formed of a mixture of polyethylene and graphite nanoplatelets can kill 99.99 per cent of bacteria which try to attach to the surface,” says Santosh Pandit, postdoctoral researcher in the research group of Professor Ivan Mijakovic at the Division of Systems Biology, Department of Biology and Biotechnology, Chalmers University of Technology.

Infections on implants are caused by bacteria that travel around in the body in fluids such as blood, in search of a surface to attach to. When they land on a suitable surface, they start to multiply and form a biofilm – a bacterial coating.

Previous studies from the Chalmers researchers showed how vertical flakes of graphene, placed on the surface of an implant, could form a protective coating, making it impossible for bacteria to attach – like spikes on buildings designed to prevent birds from nesting. The graphene flakes damage the cell membrane, killing the bacteria. But producing these graphene flakes is expensive, and currently not feasible for large-scale production.

“But now, we have achieved the same outstanding antibacterial effects, but using relatively inexpensive graphite nanoplatelets, mixed with a very versatile polymer. The polymer, or plastic, is not inherently compatible with the graphite nanoplatelets, but with standard plastic manufacturing techniques, we succeeded in tailoring the microstructure of the material, with rather high filler loadings, to achieve the desired effect. And now it has great potential for a number of biomedical applications,” says Roland Kádár, Associate Professor at the Department of Industrial and Materials Science at Chalmers.

The nanoplatelets on the surface of the implants prevent bacterial infection but, crucially, without damaging healthy human cells. Human cells are around 25 times larger than bacteria, so while the graphite nanoplatelets slice apart and kill bacteria, they barely scratch a human cell.

“In addition to reducing patients’ suffering and the need for antibiotics, implants like these could lead to less requirement for subsequent work, since they could remain in the body for much longer than those used today,” says Santosh Pandit. “Our research could also contribute to reducing the enormous costs that such infections cause health care services worldwide.”

In the study, the researchers experimented with different concentrations of graphite nanoplatelets and the plastic material. A composition of around 15-20 per cent graphite nanoplatelets had the greatest antibacterial effect – providing that the morphology is highly structured.

“As in the previous study, the decisive factor is orienting and distributing the graphite nanoplatelets correctly. They have to be very precisely ordered to achieve maximum effect,” says Roland Kádár.

The study was a collaboration between the Division of Systems and Synthetic Biology at the Department of Biology and Biological Engineering, and the Division of Engineering Materials at the Department of Industrial and Materials Science at Chalmers, and the medical company Wellspect Healthcare, who manufacture catheters, among other things. The antibacterial surfaces were developed by Karolina Gaska when she was a postdoctoral researcher in the group of Associate Professor Roland Kádár.

The researchers’ future efforts will now be focused on unleashing the full potential of the antibacterial surfaces for specific biomedical applications.

Thursday, 16 April 2020

Biologists
at the University of California San Diego are drawing parallels from newly
developed models of the common fruit fly to help lay the foundation for novel
therapies to fight the pathogen's spread.

As
with most bacterial pathogens, C. difficile secretes toxins that enter host
cells, disrupt key signaling pathways and weaken the host's normal defense
mechanisms. The most potent strains of C. difficile unleash a two-component toxin
that triggers a string of complex cellular responses, culminating in the
formation of long membrane protrusions that allow the bacteria to attach more
effectively to host cells.

UC San Diego
scientists created strains of fruit flies that are capable of expressing the
active component of this toxin, known as "CDTa." The strains allowed
them to study the elaborate mechanisms underlying CDTa toxicity in a live model
system focused on the gut, which is key since the digestive system of these
small flies is surprisingly similar to that of humans.

The
fruit fly model gave the researchers a clear path to examine genetic
interactions disrupted at the hands of CDTa. They ultimately found that the
toxin induces a collapse of networks that are essential for nutrient
absorption. As a result, the model flies' body weight, fecal output and overall
lifespan were severely reduced, mimicking symptoms in human C.
difficile-infected patients.

Wednesday, 15 April 2020

The novel human coronavirus SARS-CoV-2 has become a global health concern causing severe respiratory tract infections in humans. Human-to-human transmissions have been described, probably via droplets but possibly also via contaminated hands or surfaces. In a recent review on the persistence of human and veterinary coronaviruses on inanimate surfaces it was shown that human coronaviruses such as Severe Acute Respiratory Syndrome (SARS) coronavirus, Middle East Respiratory Syndrome (MERS) coronavirus or endemic human coronaviruses (HCoV) can persist on inanimate surfaces like metal, glass or plastic for up to 9 days. Some disinfectant agents effectively reduce coronavirus infectivity within 1 minute such 62%–71% ethanol, 0.5% hydrogen peroxide or 0.1% sodium hypochlorite. Other compounds such as 0.05%–0.2% benzalkonium chloride or 0.02% chlorhexidine digluconate are less effective. An effective surface disinfection may help to ensure an early containment and prevention of further viral spread.

Tuesday, 14 April 2020

To stop the spread of
disease, it could be used to coat phone screens and keyboards, as well as the
inside of catheters and breathing tubes, which are a major source of
healthcare-associated infections (HCAIs).

The most well-known
HCAIs are caused by Clostridioides difficile (C. difficile),
methicillin-resistant Staphylococcus aureus (MRSA) and Escherichia coli (E.
coli). They commonly occur during in-patient medical or surgical treatment, or
from visiting a healthcare setting and pose a serious health threat.

The research is the
first to show a light activated antimicrobial coating successfully killing
bacteria in low intensity, ambient light (300 Lux), such as that found in wards
and waiting rooms. Previously, similar coatings needed intense light (3,000
Lux), like that found in operating theatres, to activate their killing
properties.

The new bactericidal coating is made of tiny clusters of chemically modified
gold embedded in a polymer with crystal violet -- a dye with antibacterial and
antifungal properties.

First author, Dr Gi
Byoung Hwang (UCL Chemistry), said: "Dyes such as crystal violet are
promising candidates for killing bacteria and keeping surfaces sterile as they
are widely used to disinfect wounds. When exposed to bright light, they create
reactive oxygen species, which in turn kill bacteria by damaging their
protective membranes and DNA. This is amplified when they are paired with
metals such as silver, gold and zinc oxide."

The team of chemists,
chemical engineers and microbiologists created the bactericidal coating using a
scalable method and tested how well it killed S. aureus and E. coli against
control coatings and under different lighting conditions.

Sample surfaces were
treated with either the bactericidal coating or a control coating before being
inoculated with 100,000 colony forming units (CFU) per ml of either S. aureus
and E. coli. The growth of the bacteria was investigated under dark and white
light conditions between 200 -- 429 Lux.

They found that in
ambient light, a control coating of crystal violet in a polymer alone did not
kill either bacteria. However, in the same lighting conditions, the
bactericidal coating led to a 3.3 log reduction in the growth of S. aureus
after six hours and a 2.8 log reduction in the growth of E. coli after 24
hours.